# K970947: B-350 Ceiling Mounted C-Positioner

- Pathway: 510(k) (Traditional)
- Applicant: Omega Medical Imaging, Inc.
- Decided: May 14, 1997 after 61 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Fisher's PEGASUS Ceiling Mounted Cardiac Positioner: named in the summary without a submission number
- (no number) Philips DIAGNOST Lateral C-Arm: named in the summary without a submission number
- (no number) Fisher’s ARIEL Ceiling Mounted C-Arm: named in the summary without a submission number
- (no number) Fisher’s CPS Ceiling Mounted Imaging System: named in the summary without a submission number

## Most influential descendants
- K990055: B-400 Ceiling Mounted Possitioner, Model B-400 (1999), 0 descendants of its own

## Indications for use
To support the Diagnostic Source Assembly & the Image Receptor used in performing general purpose diagnostic fluoroscopic procedures.

Source page: https://510kreport.com/device/K970947
Methodology: https://510kreport.com/methodology